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All the top Biotech & Pharma news in one daily newsletter.

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✅ The Good News ✅

THE GOOD
Approvals & Labels

Regeneron's Libtayo receives CHMP positive opinion for alternative every-six-week dosing schedule
Monoclonal antibody, oncology, regulatory - Read more

FDA approves Opus Genetics' Ryzumvi (phentolamine) for presbyopia following Ph3 success, marking second label indication
Small molecule, ophthalmology, alpha-adrenergic antagonist, presbyopia, phentolamine - Read more

THE GOOD
Business Development & Partnerships

Paradromics, Siemens Healthineers collaborate to develop multimodal imaging platform supporting brain-computer interfaces
Research collaboration, diagnostics, neurological, digital health, brain-computer interfaces - Read more

Roche, Hansoh Pharmaceutical expand ADC alliance with broad portfolio deal, $400M upfront, $15B potential
Licensing deal, oncology, antibody-drug conjugate, milestone payments, royalties - Read more

Ekalia, Telix Pharmaceuticals collaborate to accelerate Astatine-211 production infrastructure in the United States
Manufacturing agreement, oncology, radiopharmaceuticals, targeted alpha therapy, joint venture - Read more

Algorae Pharmaceuticals, Umedica Laboratories sign MOU and licence supply agreement for Australian pharmaceutical market
Licensing deal, manufacturing agreement, small molecule, commercialization - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Disc Medicine's (bitopertin) Ph3 trial meets all endpoints for erythropoietic protoporphyria, paving way for FDA resubmission
Small molecule, metabolic, erythropoietic protoporphyria, glycine transporter 1 inhibitor, rare disease - Read more

AbbVie's ABBV-466 (trosunilimab + Skyrizi) combo beats Skyrizi monotherapy in Ph2 Crohn's disease trial
Antibody, autoimmune, monoclonal antibody, Crohn's disease, combination therapy, IL-23 inhibitor - Read more

Veradermics' VDPHL01 (minoxidil) meets Ph3 endpoints, improving hair coverage in male androgenetic alopecia
Small molecule, dermatological, extended-release formulation, androgenetic alopecia, minoxidil, pattern hair loss - Read more

OSE Immunotherapeutics' Tedopi (OSE2101) meets primary endpoint in Ph2 trial for metastatic non-small cell lung cancer
Vaccine, cancer, peptide vaccine, non-small cell lung cancer, combination therapy, anti-PD1 - Read more

THE GOOD
Fundraises

Nouscom raises $135M Series D for pivotal cancer-preventing vaccine trial in Lynch syndrome
Cancer vaccine, oncology, Lynch syndrome, rare disease, immunotherapy, clinical-stage - Read more

Flavii Therapeutics raises €843K ($947.4K), advancing epigenetic therapies for neurological disorders
Neurological, small molecule, epigenetics, preclinical, neurodegeneration - Read more

Microbiotica raises $48M Series C to advance MB310 into Phase 2 ulcerative colitis trials
Clinical-stage, microbiome therapeutics, ulcerative colitis, autoimmune, oral drug delivery - Read more

THE GOOD
Investments

Sanofi breaks ground on new Frankfurt insulin manufacturing facility, targeting full production by 2032
Insulin, diabetes, operational, manufacturing - Read more

THE GOOD
Mergers & Acquisitions

Merck KGaA acquires Silence Therapeutics for $1.3B, gaining promising siRNA blood cancer drug divesiran
siRNA, oncology, rare disease, major transaction, strategic - Read more

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❌ The Bad News ❌

THE BAD
Clinical Trials

TWi Biotechnology's AC-203 Ph2/3 trial misses primary endpoint in epidermolysis bullosa simplex
Small molecule, skin disease, epidermolysis bullosa, pain management, phase 2/3 trial - Read more

THE BAD
Layoffs

Enlivex cuts 60% of workforce, scraps preclinical R&D, slashes exec salaries to fund osteoarthritis trial
Cell therapy, musculoskeletal, cost reduction, operational - Read more

THE BAD
Politics & Policy

Roche pauses future Germany investments amid healthcare cost-cutting policies, joining pharma industry pullback
Pharmaceutical investment, healthcare policy, strategic, financial, competitive - Read more

China proposes export restrictions on AI, biotech technologies, potentially impacting global biopharma licensing deals
Cell and gene therapy, rare disease, export controls, strategic - Read more

THE BAD
Strategic Plans

Novartis halts Ph2 study of Fabhalta (iptacopan) in lupus nephritis, citing strategic reasons over safety or efficacy concerns
Small molecule, autoimmune, complement inhibitor, lupus nephritis, factor B inhibitor - Read more

You’re all caught up on the latest Pharma & Biotech News!

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